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Centers for Disease Control and Prevention

National Center for Immunization and Respiratory Diseases

Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 

use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.

Maternal/Pediatric Respiratory Syncytial Virus (RSV) 

Work Group

Sarah S. Long, MD

Chair, Maternal/Pediatric RSV Work Group

ACIP General Meeting

September 22, 2023
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Each year in U.S. children aged less than 5 years, 

RSV is associated with...

~1,500,0003

outpatient visits

~520,0003

emergency department visits

58,000–80,0003,4

hospitalizations

100–3001,2

deaths

1Thompson et al, JAMA, 2003; 2Hansen et al, JAMA Network Open, 2022; 3Hall et al, NEJM, 2009; 4McLaughlin et al, J Infect Dis, 2022 (*estimate 80,000 hospitalizations in infants 

<1y) 
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▪ Most (68%) infants are infected in the first year of life and 

nearly all (97%) by age 2 years2

▪ 2-3% of young infants will be hospitalized for RSV3,4,5

▪ RSV is a common cause of lower respiratory tract infection 

in infants 

▪ Highest RSV hospitalization rates occur in first months of 

life and risk declines with increasing age in early 

childhood3,5

▪ 79% of children hospitalized with RSV aged <2 years had no 

underlying medical conditions3

RSV is the leading cause of hospitalization in U.S. 

infants1

1Suh et al. JID 2022; 2Glezen et al, Arch Dis Child, 1986; 3Hall et al, Pediatrics, 2013; 4Langley & Anderson, PIDJ, 2011; 5CDC NVSN data

Image: Goncalves et al. Critical Care 

Research and Practice 2012
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▪ Epidemiology and burden of RSV in infants

▪ Virology and immunology of RSV

▪ Safety and efficacy of RSVpreF

▪ Cost effectiveness analysis for RSVpreF – CDC model

▪ Cost effectiveness analysis for RSVpreF – Comparison with manufacturer model

▪ Evidence to Recommendations framework for RSVpreF

▪ Clinical considerations for RSVpreF

Previous maternal/pediatric RSV ACIP presentations on 

RSVpreF vaccine
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▪ On August 21, 2023, FDA approved Pfizer RSVpreF vaccine for use in pregnant people for the 

prevention of RSV lower respiratory tract disease and severe lower respiratory tract disease in 

infants from birth to 6 months of age

▪ Approved as a single dose to be given at 32–36 weeks gestation

– In phase 2b and 3 trials, vaccination was given during 24–36 weeks gestation 

– A numerical imbalance in preterm births was observed in RSVpreF vaccine compared to 

placebo recipients in two clinical studies

– Available data are insufficient to establish or exclude a causal relationship between preterm 

birth and RSVpreF

– Additionally, a numerical imbalance in hypertensive disorders of pregnancy was observed in 

RSVpreF vaccine compared to placebo recipients

FDA approval for RSVpreF vaccine

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants | FDA

Package Insert -ABRYSVO (STN 125768) (fda.gov)

August 21, 2023 Approval Letter -ABRYSVO (STN 125768) (fda.gov)
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▪ Starting dosing at 32 weeks gestation can reduce the potential risk of and complications from 

preterm birth until additional safety data are available

– Avoids the risk of extremely preterm births, where there is substantive morbidity and 

mortality, and very preterm births

– Similar vaccine efficacy in 32-36 weeks gestation compared to the overall study population

▪ FDA has required the manufacturer to conduct post-marketing studies to assess preterm birth 

and hypertensive disorders of pregnancy, including pre-eclampsia

FDA approval for RSVpreF vaccine (cont.)

FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants | FDA

Package Insert -ABRYSVO (STN 125768) (fda.gov)

August 21, 2023 Approval Letter -ABRYSVO (STN 125768) (fda.gov)
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▪ On August 3, 2023, ACIP recommended nirsevimab for RSV prevention in infants

– Infants aged <8 months born during or entering their first RSV season are 

recommended to receive one dose of nirsevimab (50 mg for infants <5 kg and 100 

mg for infants ≥5 kg)

– Children aged 8–19 months who are at increased risk of severe RSV disease and 

entering their second RSV season are recommended to receive one dose of 

nirsevimab (200 mg) 

RSVpreF vaccine is one of two available preventive 

products for RSV in infants
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▪ A person develops active immunity from infection or vaccination

– Triggers an immune response

– Immunologic memory provides prolonged protection that may be lifelong

▪ Passive immunity is transfer of preformed antibody produced externally to provide 

protection to the recipient

– From mother to baby through transplacental or breastmilk transfer

– Direct administration of antibodies, such as IVIG or monoclonal antibodies

– Provides temporary protection that wanes with time

Both nirsevimab and maternal RSV vaccine provide passive 

immunity

IVIG= Intravenous ImmunoglobulinTherapy

https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm
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Agenda: Friday September 22, 2023

RSVpreFVaccine Safety Surveillance in Pregnancy from 

The Vaccine Safety Datalink

Dr. Malini DeSilva (HealthPartners 

Institute) 

Maternal RSV vaccine safety monitoring in the Vaccine 

Adverse Event Reporting System (VAERS) and V-safe

Dr. Pedro Moro (CDC/NCEZID)

Economic analysis of RSVpreF maternal vaccination Dr. David Hutton (University of 

Michigan)

Economics of Preventing Respiratory Syncytial Virus 

Disease among US Infants by Maternal Vaccination Prior 

to Birth

Dr. Ismael Ortega-Sanchez 

(CDC/NCIRD)

Evidence to Recommendations Framework Updates: 

Pfizer Maternal RSVpreF Vaccine

Dr. Katherine Fleming-Dutra 

(CDC/NCIRD)
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Agenda: Friday September 22, 2023 (cont.)

Updated clinical considerations for use of both 

nirsevimab and Pfizer RSVpreF vaccine

Dr. Jefferson Jones (CDC/NCIRD)

Implementation considerations for maternal RSV 

vaccine

Dr. Georgina Peacock (CDC/NCIRD)

Vaccines for Childrens Resolution Dr. Jeanne Santoli (CDC/NCIRD)

Break

Public Comment

Break

Vote on recommendation and Vaccines for Children

Adult and Pediatric Immunization Schedule Addendum Dr. Sarah Schillie (CDC/NCIRD)
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▪ Should Pfizer RSVpreF vaccine be recommended for pregnant people to be given 

during 32 through 36 weeks gestation to prevent RSV lower respiratory tract infection 

in infants?

Policy Question
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Work group members (External)

ACIP Members

Sarah Long (chair)

Pablo Sanchez

Oliver Brooks

Camille Kotton

Consultants

Cody Meissner (Dartmouth Geisel School of Medicine)

Helen Chu (University of Washington)

Natasha Halasa (Vanderbilt University)

Denise Jamieson (Emory University School of Medicine)

Daniel Feikin (World Health Organization)

Carol Baker (University of Texas Health Science Center)

Kevin Ault (Western Michigan University) Liaisons

James McAuley (IDSA)

Patsy Stinchfield (NFID)

Brenna L. Hughes (ACOG)

Nicole Chaisson (AAFP)

Sean O’Leary (AAP)

Jennifer Schuster (PIDS)

Molly Howell (AIM)

GRADE/EtR Consultants

Doug Campos-Outcalt

Rebecca Morgan

Ex Officio Members

Rachel Zhang (FDA-CBER)

Nicholas Geagan (FDA-CBER)

Judy Beeler (FDA-CBER)

Yodit Belew (FDA-CDER)

Prabha Viswanathan (FDA-CDER)

Sonnie Kim (NIH-NIAID)

April Killikelly (Public Health Agency of Canada)

Winnie Siu (Public Health Agency of Canada)

Valerie Marshall (OIDP/OASH)

Jessica Lee (CMS/CMCS)

Terry Dalle-Tezze (HRSA)

Lucia Lee (FDA-CBER)

Robin Wisch (FDA-CBER)
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Work group members (CDC)

Amber Winn

Chris Taylor

Tami Skoff

Angie Campbell

Michael Melgar

Amanda Payne

Nicole Dowling

Noelle Molinari

Claire Midgley

Fiona Havers

Pragna Patel

Andrea Sharma

Amadea Britton

Ruth Link-Gelles

Danielle Moulia

Megan Wallace

Monica Godfrey

Karen Broder

Naomi Tepper

Heidi Moline

CDC ACIP Staff

Melinda Wharton

Stephanie Thomas

Jessica MacNeil

Hannah Rosenblum

Derrell Powers

Raigan Wheeler

Sally Ezra

Elizabeth Greene

Manisha Patel

Tom Shimabukuro

Demorah Hayes

Latifah Boyce

CDC

Katherine Fleming-Dutra (co-lead)

Jefferson Jones (co-lead)

Meredith McMorrow

Mila Prill

Natalie Thornburg

Aron Hall

Ismael Ortega-Sanchez

Melissa Coughlin

Jamison Pike

Lauren Roper

A. Patricia Wodi

Neil Murthy

Christine Olson

Anne Hause

Andrew Leidner

David Shay

Sarah Meyer
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For more information, contact CDC 1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the official 

position of the Centers for Disease Control and Prevention.

Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation 

use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.